Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia
Information source: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Dyslipidemia
Intervention: Rosuvastatin (Drug); Simvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Taipei Veterans General Hospital, Taiwan Official(s) and/or principal investigator(s): Chii-Min Hwu, MD, Principal Investigator, Affiliation: Taipei Veterans General Hospital, Taiwan Wayne H Sheu, MD,phD, Principal Investigator, Affiliation: Taichung Veterans General Hospital
Summary
This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration
study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with
type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with
simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is
superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and
non-HDL-C (<130 mg/dL).
Clinical Details
Official title: A Phase IV, Randomized, Open-label, Parallel-arm, Comparative and Forced- Titration Study to Compare the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Patients With Type 2 DM and Dyslipidemia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Primary outcome: The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment
Secondary outcome: Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12; Percentage of patients achieving the LDL-C goal of <70 mg/dL at Week;The mean percent change from baseline in lipid profile at week 4 and week 12;
Detailed description:
The duration of patient participation will be 18 weeks consisting of a 1-week screening
period, a 5-week lead-in period, followed by a 12-week treatment period.
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male and female between the ages of 20-75 years.
2. Female patients post menopausal, hysterectomized or if of childbearing potential
using a reliable method of birth control.
3. Diagnosed with type 2 diabetes mellitus.
4. Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL
5. Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no
change in the category of anti-diabetic agents, but the dose is adjustable).
6. All patients give written informed consent.
Exclusion Criteria:
1. A history of hypersensitivity to statins.
2. A history of rhabdomyolysis or hereditary muscle disorders.
3. Insulin-treated patients.
4. Patient with any conditions of acute or chronic pancreatitis.
5. Creatine kinase ≧3-fold upper limit of normal (ULN).
6. Patients with an estimated creatinine clearance (see note)≦30 ml/min or bilirubin
≧1. 5-fold ULN, or chronic active hepatitis or liver function impairment (AST and ALT
≧3-fold ULN).
7. Overt proteinuria (repeat spot urine protein >300mg/dl by dipstick method).
8. Patients are taking cyclosporine.
9. A history of homozygous familial hypercholesterolemia or familial
dysbetalipoproteinemia.
10. Patients with alcohol and drug abuse in past 3 years.
11. Serious or unstable medical or psychological conditions.
12. Hypothyroidism (TSH > 5 μIU/mL).
13. In the investigator's opinion, continuation in the study would be detrimental to the
patient's well-being or might confound the clinical trial.
Locations and Contacts
Taichung Veterans General Hospital, Taichung, Taiwan
Taipei Veterans General Hospital, Taipei, Taiwan
Additional Information
Starting date: June 2006
Last updated: December 5, 2011
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